Tools and methods for vaginal access

ABSTRACT

An access port for sealing an opening of a natural orifice and supplying access to a body cavity through the natural orifice including: a sealing unit; an unobstructed single lumen cannula extending to the body cavity; a connector connecting the cannula to the sealing unit; an access opening through the sealing unit to the single lumen; a cap including a plurality of cap openings configured to seal between medical instruments inserted into the openings and the access opening.

RELATED APPLICATIONS

This application claims the benefit of priority of U.S. ProvisionalPatent Application No. 62/549,097 filed on Aug. 23, 2017; U.S.Provisional Patent Application No. 62/549,078 filed on Aug. 23, 2017;U.S. Provisional Patent Application No. 62/558,460 filed on Sep. 14,2017; and U.S. Provisional Patent Application No. 62/558,469 filed onSep. 14, 2017; the contents of which are incorporated by reference as iffully set forth herein in their entirety.

This application is also a part of a set of filings which are co-filed,and co-assigned:

U.S. patent application Ser. No. 16/109,891 filed on Aug. 23, 2018entitled “TOOLS AND METHODS FOR VAGINAL ACCESS”;

PCT Patent Application No. PCT/IL2018/050934 having International FilingDate of Aug. 23, 2018 entitled “TOOLS AND METHODS FOR VAGINAL ACCESS”;

Canadian Patent Application No. 3,015,084 filed on Aug. 23, 2018entitled “TOOLS AND METHODS FOR VAGINAL ACCESS”;

U.S. patent application Ser. No. 16/109,893 filed on Aug. 23, 2018entitled “TOOLS AND METHODS FOR VAGINAL ACCESS”;

Canadian Patent Application No. 3,015,089 filed on Aug. 23, 2018entitled “TOOLS AND METHODS FOR VAGINAL ACCESS”;

U.S. patent application Ser. No. 16/109,880 filed on Aug. 23, 2018entitled “TOOLS AND METHODS FOR VAGINAL ACCESS”; and

U.S. patent application Ser. No. 16/109,879 filed on Aug. 23, 2018entitled “TOOLS AND METHODS FOR VAGINAL ACCESS”;

the disclosures of which are all incorporated herein by reference.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to aminimally invasive surgery and more particularly but not exclusively totools and methods to access a body cavity through a natural orifice andmore particularly but not exclusively to culdoscopic access to theintraperitoneal space.

U.S. Pat. No. 8,608,652 appears to disclose, “A surgical method, system,kit, and various devices,” . . . “for use in, among other things,vaginal entry during a natural orifice translumenal endoscopic surgicalprocedure. A system and/or method provide for the rapid creation of aconduit and/or multiple ports in a natural orifice, such as a patient'svagina, while accommodating anatomical variation to reduce the need toexcise additional tissue from the patient.”

The contents of the above applications are all incorporated by referenceas if fully set forth herein in their entirety.

SUMMARY OF THE INVENTION

Following are examples of some embodiments of the invention. Features ofone example may be combined with features of one or more other examples,unless expressly prohibited and form additional examples of someembodiments of the invention.

Example 1

An access port for sealing an opening of a natural orifice and supplyingaccess to a body cavity through the natural orifice comprising:

a sealing unit;

an unobstructed single lumen cannula extending to said body cavity;

a connector connecting said cannula to said sealing unit;

an access opening through the sealing unit to said single lumen;

a cap including a plurality of cap openings configured to seal betweenmedical instruments inserted into the openings and said access opening.

Example 2

The access port of Example 1, wherein said connector comprises aconnector lumen which defines said access opening.

Example 3

The access port of Example 2, wherein said connector lumen comprisesproximal and distal openings, said proximal opening disposed proximal toa proximal face of said sealing unit, said distal opening disposeddistal of a distal face of said sealing unit.

Example 4

The access portion according to any one of Examples 1-3, wherein one orboth of proximal and distal openings of said connector has a flange.

Example 5

The access port according to any one of Examples 1-4, comprising anopening through said sealing unit to the natural orifice.

Example 6

The access port according to any one of Examples 1-5, wherein saidnatural orifice is a vagina.

Example 7

The access port of according to any one of Examples 1-6, wherein saidcannula is open to an intraperitoneal cavity through said naturalorifice.

Example 8

The access port according to any one of Examples 1-7, comprising asheath extending from a proximal face of said sealing unit, through saidsealing unit and through to said cannula lumen and extending within atleast a portion of a length of said cannula lumen.

Example 9

The access port according to any one of Examples 8, comprising a cannulaseal configured to seal one or both of a proximal opening of saidcannula and a proximal opening of said sheath.

Example 10

The access port according to any one of Examples 1-8, comprising a portelement describing a channel through said sealing unit and opening tosaid cavity.

Example 11

The access port according to any one of Examples 1-9, comprising a portelement describing a channel through said sealing unit and opening intosaid lumen of said cannula.

Example 12

The access port of Example 11, wherein said port element includes asheath extending from a proximal face of said sealing unit, through saidcannula and extending within a least a portion of said cannula.

Example 13

The access port according to any one of Examples 1-12, wherein atransverse cross section of said single lumen has a long dimension and ashort dimension; and

wherein each cap opening has a width smaller than said short dimensionand the sum of widths of said plurality of cap openings is greater thansaid short dimension and less than said long dimension.

Example 14

The access port of Example 13, wherein said cross section of said singlelumen has, in at least one dimension, a width of at least 21 mm.

Example 15

The access port according to any one of Examples 1-14, wherein atransverse cross section of said single lumen has long dimension andshort dimension and at least one of said openings has a width at least90% the short dimension.

Example 16

A kit for providing access to a cannula leading to a body cavity througha seal on a natural orifice comprising:

a connector comprising:

a channel with a distal opening and a proximal opening and configured toconnect to

configured to pass through said seal and attach to a cannula passingthrough the orifice to the body cavity, said connector having a distalopening on an inner side of said seal and a proximal opening to an outerside of said seal;

a cap comprising a plurality of openings and sized and shaped to seal alumen of said cannula.

Example 17

The kit of Example 16 comprising:

a sheath sized and shaped to pass through said connector and extendwithin at least a portion of said cannula lumen.

Example 18

The kit of Example 17 comprising a sealing element sized and shaped tofit to one or both of said sheath and said cannula and includingelastically bendable flexible portions which, when elastically relaxed,close a lumen of said sealing element to seal one or both of said sheathand said cannula.

Example 19

The kit according to any one of Examples 17-18, wherein said cap issized and shaped to attach to one or more of a proximal opening of saidcannula, a proximal opening of said sheath, and a proximal opening ofsaid connector.

Example 20

The kit according to any one of Examples 16-19, wherein said distalopening has a cross section with a long dimension and a short dimensionand wherein said long dimension is at least twice said short dimension.

Example 21

An access channel for access to a body cavity through a natural orificecomprising:

a variable length unobstructed channel including:

a rigid cannula having a distal opening configured to fit through anincision in a wall of the orifice;

a rigid tubular extension for said cannula; a distal opening of saidextension fitting to a proximal opening of the cannula and joining alumen of said cannula to a lumen of said extension to form said variablelength channel between said distal opening of said cannula and aproximal opening of said extension;

said extension sliding longitudinally with respect to said cannula toextend and contract a length of said variable length channel by at least25% of a maximal length of the channel;

wherein a cross section of the channel has a long dimension at leasttwice a short dimension of said cross section.

Example 22

The access channel of Example 21, comprising:

a seal attached to said extension shaped and sized to limitcommunication of pressure between said incision and an external openingof the orifice.

Example 23

The access channel according to any one of Examples 21-22, wherein saidextension is attached to said seal by passing through a channel in saidseal.

Example 24

The access channel according to any one of Examples 21-23, comprising:

a handle rigidly joined to said cannula and extending proximally pastsaid seal.

Example 25

The access channel of Example 24, wherein said handle passes through aport in said seal.

Example 26

The access channel according to any one of Examples 21-25, comprising:

a handle rigidly joined to said distal opening of said cannula andextending proximally past said proximal opening of said extension.

Example 27

The access channel according to any one of Examples 21-26, furthercomprising:

a dilator including:

a tapered tip for enlarging said incision; and

a body at least as long as said cannula and fitting through saidchannel.

Example 28

The access channel of Example 27, wherein a cross section of an outercontour of said dilator fills at least 80% of the area of the internalcross section of said cannula.

Example 29

An access channel to a body cavity through a natural orifice comprising:

a distal portion including a distal opening configured for insertionthrough an incision into the body cavity;

a proximal portion disposed within said natural orifice and including aproximal opening movable with respect to said distal portion;

a lumen joining said distal opening with said proximal opening; and

a handle rigidly attached to said distal portion and extendingproximally past said proximal opening.

Example 30

The access channel of Example 29, wherein a cross section of the channelhas a long dimension at least twice a short dimension of said crosssection.

Example 31

The access channel of Example 30, comprising:

a seal attached to said proximal portion, said seal shaped and sized tolimit communication of pressure between said incision and an externalopening of the orifice; and

wherein said handle passes through a port element in said seal.

Example 32

The access channel according to any one of Examples 29-31, comprising:

a seal attached to said proximal portion, said seal shaped and sized tolimit communication of pressure between incision and an external openingof the orifice.

Example 33

The access channel according to any one of Examples 29-32, comprising:

a dilator including a tapered tip for enlarging said incision and

a body at least as long as said distal portion and fitting through saidchannel.

Example 34

The access channel of Example 33, wherein a cross section of saiddilator fills at least 80% of the area of the internal cross sectionalof said distal portion.

Example 35

A method for providing access to a body cavity through an orificecomprising:

inserting a distal portion of a cannula including a distal openingthrough a tissue separating said cavity from said orifice,

during said inserting, maintaining a position of a proximal portion of acannula including a proximal opening inside said orifice with respect toone or more of said orifice and said cavity; and

inserting a tool through a lumen of said cannula, from said proximalopening to said distal opening through said tissue into said bodycavity.

Example 36

The method of Example 35, comprising:

joining said proximal opening of said cannula to a distal opening of atubular extension, a combined lumen said cannula and said extensionproviding communication between said distal opening of the cannula and aproximal opening of said extension; and

wherein said proximal opening of said extension is movable with respectto said distal opening of said cannula; and

wherein said inserting is through said proximal opening of saidextension.

Example 37

The method of Example 36, comprising:

sealing an opening of the natural orifice around extension with a sealelement.

Example 38

The method Example 37, comprising:

providing a plurality of ports from outside said seal element to saidlumen of said extension.

Example 39

The method according to any one of Examples 36-37, comprising:

inserting multiple tools independently and simultaneously from outsidesaid orifice through said combined lumen into said cavity.

Example 40

The method according to any one of Examples 35-39, comprising:

stabilizing said cannula from outside the orifice.

According to an aspect of some embodiments of the invention, there isprovided an access channel for access to a body cavity through a naturalorifice including: a variable length unobstructed channel including arigid cannula having a distal opening configured to fit through anincision in a wall of the orifice; a rigid tubular extension for thecannula; a distal opening of the extension fitting to a proximal openingof the cannula and joining a lumen of the cannula to a lumen of theextension to form the variable length channel between the distal openingof the cannula and a proximal opening of the extension; the extensionsliding longitudinally with respect to the cannula to extend andcontract a length of the variable length channel by at least 25% of amaximal length of the channel wherein a cross section of the channel hasa long dimension at least twice a short dimension of the cross section.

According to some embodiments of the invention, the access channelfurther includes: a seal attached to the extension shaped and sized tolimit communication of pressure between incision and an external openingof the orifice.

According to some embodiments of the invention, the access channelfurther includes: a handle rigidly joined to the distal opening of thecannula and extending proximally past the seal.

According to some embodiments of the invention, the handle passesthrough a port in the seal.

According to some embodiments of the invention, the access channel ofany of any further includes: a handle rigidly joined to the distalopening of the cannula and extending proximally past the proximalopening of the extension.

According to some embodiments of the invention, the access channel ofany of any further includes: a dilator including a tapered tip forenlarging the incision and a body at least as long as the cannula andfitting through the channel.

According to some embodiments of the invention, a cross section of thedilator fills at least 80% of the area of the internal cross sectionalof the cannula.

According to an aspect of some embodiments of the invention, there isprovided an access channel to a body cavity through a natural orificeincluding: a distal portion including a distal opening configured forinsertion through an incision into the body cavity; a proximal portionincluding a proximal opening movable with respect to the distal portion;a lumen joining the distal opening with the proximal opening; and ahandle rigidly attached to the distal portion and extending proximallypast the proximal opening.

According to some embodiments of the invention, a cross section of thechannel has a long dimension at least twice a short dimension of thecross section.

According to some embodiments of the invention, the access channelfurther includes: a seal attached to the proximal portion, the sealshaped and sized to limit communication of pressure between incision andan external opening of the orifice and wherein the handle passes througha port in the seal.

According to some embodiments of the invention, the access channelfurther includes: a seal attached to the proximal portion, the sealshaped and sized to limit communication of pressure between incision andan external opening of the orifice.

According to some embodiments of the invention, the access channel ofany of any further includes: a dilator including a tapered tip forenlarging the incision and a body at least as long as the distal portionand fitting through the channel.

According to some embodiments of the invention, a cross section of thedilator fills at least 80% of the area of the internal cross sectionalof the distal portion.

According to an aspect of some embodiments of the invention, there isprovided a method for providing access to a body cavity through anorifice, the orifice separated from including: inserting a distalportion of a cannula including a distal opening through a membraneseparating the cavity from the orifice, maintaining a proximal portionof a cannula including a proximal opening inside the orifice; andinserting a tool through a lumen of the cannula, from the proximalopening to out the distal opening into the body cavity.

According to some embodiments of the invention, the method furtherincludes: joining the proximal opening of the cannula to a distalopening of a tubular extension, a combined lumen the cannula and theextension providing communication between the distal opening of thecannula and a proximal opening of the extension and wherein the proximalopening of the extension is movable with respect to the distal openingof the cannula and wherein the inserting is through the proximal openingof the extension.

According to some embodiments of the invention, the method furtherincludes: sealing an opening of the natural orifice around extension.

According to some embodiments of the invention, the method furtherincludes: closing the proximal opening of the extension and providing aplurality of ports from outside the seal to the lumen of the extension.

According to some embodiments of the invention, the method furtherincludes: inserting multiple tools independently and simultaneously fromoutside the orifice through the combined lumen into the cavity.

According to some embodiments of the invention, the method furtherincludes: stabilizing the cannula from outside the orifice.

According to an aspect of some embodiments of the invention, there isprovided a sealing unit for sealing an opening of a natural orifice andsupplying access to a body cavity through the orifice including: aconnector to an unobstructed single lumen trocar on a distal face of thesealing unit a plurality of sealable access openings through the sealingunit to the single lumen; wherein a cross section of the single lumenhas long dimension and short dimension and each opening has a widthsmaller than the small dimension and the sum of widths of the openingsis greater than the short dimension and less than the long dimension.

According to some embodiments of the invention, a cross section of thesingle lumen has long dimension and short dimension and at least one ofthe openings has a width at least 90% the short dimension.

According to some embodiments of the invention, a cross section of thesingle lumen has in at least one dimension a width of at least 21 mm.

According to some embodiments of the invention, the trocar is open to anintraperitoneal cavity through a natural orifice, the sealing unitfurther including an opening to the orifice.

According to an aspect of some embodiments of the invention, there isprovided an access port for access to a body cavity through a naturalorifice including: one or more ports opening to the cavity and at leastone port opening to the natural orifice outside of the cavity.

According to some embodiments of the invention, the access port furtherincludes: a seal for preserving a positive pressure in the cavity.

According to some embodiments of the invention, the access port furtherincludes: a seal for preserving a positive pressure in the orifice.

According to some embodiments of the invention, the access port furtherincludes: a connector connecting the one or more ports to anunobstructed single lumen trocar passing and wherein the one or moreports open to the single lumen.

According to some embodiments of the invention, a cross section of thesingle lumen has long dimension and short dimension and wherein each ofthe one or more ports has a width smaller than the small dimension andthe sum of widths of the openings is greater than the short dimensionand less than the long dimension.

According to some embodiments of the invention, a cross section of thesingle lumen has long dimension and short dimension and at least one ofthe one or more ports has a width at least 90% the short dimension.

According to some embodiments of the invention, a cross section of thesingle lumen has in at least one dimension a width of at least 21 mm.

According to an aspect of some embodiments of the invention, there isprovided a kit for providing access to trocar leading to a body cavitythrough a seal on a natural orifice including: an adapter configured topass through the seal and attach to a cannula passing through theorifice to the body cavity, the adapter having a distal opening on aninner side of the seal and a proximal opening to an outer side of theseal, an orifice access port configured to pass through the seal andprovide access to the natural orifice outside the trocar.

According to some embodiments of the invention, the kit furtherincludes: a least two cavity access ports separately sealable andopening through the adapter.

According to some embodiments of the invention, the kit furtherincludes: a unitary cap closing over the adapter and the second.

According to some embodiments of the invention, the distal opening has across section with a long dimension and a short dimension and whereinthe long dimension is at least twice the short dimension.

According to some embodiments of the invention, the long dimension is atleast 21 mm.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example and for purposes of illustrativediscussion of embodiments of the invention. In this regard, thedescription taken with the drawings makes apparent to those skilled inthe art how embodiments of the invention may be practiced.

In the drawings:

FIG. 1 is a schematic illustration of a variable length channel insertedthrough a natural orifice in accordance with embodiments of the currentinvention;

FIG. 2 is a schematic illustration of an access channel inserted througha natural orifice to a body cavity sealed to a natural orifice inaccordance with embodiments of the current invention;

FIG. 3 is a flow chart illustration of a method of accessing a bodycavity through a natural orifice in accordance with embodiments of thecurrent invention;

FIG. 4 is a flow chart illustration of a method of sealing a naturalorifice access channel to body cavity in accordance with embodiments ofthe current invention;

FIG. 5 is a photograph of components of an access channel to a bodycavity in accordance with embodiments of the current invention;

FIG. 6A is a schematic illustration of inserting a cannula into anatural orifice in accordance with embodiments of the current invention;

FIG. 6B is a schematic illustration sealing a channel to a naturalorifice in accordance with embodiments of the current invention;

FIG. 7 is a photograph of a variable length channel and orifice seal inaccordance with embodiments of the current invention;

FIG. 8A is a schematic illustration of preparing an orifice seal inaccordance with embodiments of the current invention;

FIG. 8B is a simplified schematic of an orifice seal and a port element,according to some embodiments of the invention;

FIG. 9 is a photograph of a variable length channel and orifice sealconnected to a support in accordance with embodiments of the currentinvention;

FIG. 10 is a photograph of an orifice seal end cap in accordance withembodiments of the current invention;

FIG. 11 is a schematic illustration of a channel inserted through avagina into a pouch of Douglas in accordance with embodiments of thecurrent invention;

FIG. 12 is a flow chart illustration of a method of providing sealedaccess to body cavity through a sealed natural orifice and/or sealedchannel, according to some embodiments of the invention; and

FIGS. 13A-J are simplified schematics illustrating access and/or sealingapparatus, according to some embodiments of the invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

Overview

The present invention, in some embodiments thereof, relates to aminimally invasive surgery and more particularly but not exclusively totools and methods to access a body cavity through a natural orifice andmore particularly but not exclusively to culdoscopic access to theintraperitoneal space.

An aspect of some embodiments of current invention relates to a variablelength channel through a natural orifice to a body cavity. In someembodiments, the channel may include a distal cannula and/or a proximalextension of the cannula. Optionally the proximal extension may movewith respect to the cannula. For example, a distal opening of thecannula may be inserted into the body cavity through an incision in awall of the orifice. Optionally, the proximal extension may bepositioned to supply communication between a proximal opening of thecannula and an opening of the orifice. The length and/or position of theextension is optionally adjusted to account for the geometry of theorifice. In some embodiments, the cannula is a single lumen cannula.

In some embodiments, the cannula may include a proximally extendinghandle. For example, the handle may extend from the cannula out theopening of the orifice. Optionally, the handle is longer than theproximal extension of the channel. Optionally the handle is rigidlyattached to the cannula. Optionally the handle may be graduated forexample to indicate a depth of insertion of the cannula. In someembodiments a support may be supplied with a mount configured to holdthe handle outside the subject.

In some embodiments, each section (for example the cannula and/or theextension) of the channel may be rigid. Alternatively or additionally, across section of each section may be fixed. For example, the outer crosssection may be shaped to fit through the orifice. Optionally, the innerlumen of the channel may be adjusted to fit one or more tools, forexample including a catheter and/or an endoscope. Optionally a track maybe included in the channel. For example, the track may separate betweentools inside the channel and/or the track may guide a tool from aproximal opening of the channel (e.g. a proximal opening of theextension) to a distal opening of the channel (e.g. a distal opening ofthe cannula). Alternatively or additionally one or more section of thechannel may be flexible.

In some embodiments, a proximal portion of the channel moves withrespect to the distal portion. In some embodiments, sections movetelescopically with respect to each other. For example, relativemovement may lengthen and/or shorten the channel to fit between theopening of the orifice and the incision between the orifice and the bodycavity. For example, a proximal portion of the cannula may slide withina distal opening of the extension and/or a distal portion of theextension may slide within a proximal opening of the cannula. Optionallyan opening of the proximal portion or the channel (e.g. the extension)is accessible from outside the orifice and/or through the opening of theorifice. For example, each section of the channel may be shorter thanthe orifice.

In the some embodiments, the proximal extension of the channel may beconfigured for sealing the orifice. For example, the proximal extensionmay include an adapter (for example a flange) configured far attachingto a seal of an access channel (for example a GelPOINT® cap availablefrom Applied Medical 22872 Avenida Empresa, Rancho Santa Margarita,Calif. 92688). Optionally, the proximal extension may be stabilized inthe orifice by connection to the subject, for example by connection to aseal of the orifice and/or a wound retractor. Alternatively oradditionally, the extender may include a handle and/or be attached to astabilizer outside the subject.

In some embodiments the channel may be configured for use in a vagina.For example the channel may be configured to fit through an opening ofthe vagina and/or to reach a Pouch of Douglas. In some embodiments, thechannel is configured for use in an anus (e.g. cavity is the abdominalcavity), esophagus (e.g. cavity is a portion of the digestive tract e.g.cavity is the abdominal cavity), trachea (e.g. cavity is the lung/s,e.g. cavity is the thoracic cavity). In some embodiments, there is nomembrane between the natural orifice and the cavity, in which case, insome embodiments, a seal is introduced between the orifice and thecavity.

Although adjustable length cannulas are described in detail within thisapplication it is to be understood that apparatus and/or methodsdescribed are, in some embodiments, used with a cannula of fixed length(e.g. without an extension). Where, for example, in some embodiments, akit includes a plurality of different length cannulas and a cannula isselected based on patient anatomy dimension/s and/or the procedure to beperformed.

An aspect of some embodiments of current invention relates to a methodof providing access to a body cavity, for example, via a naturalorifice. In some embodiments, access is provided to a body cavitythrough an outer skin incision e.g. laparoscopic surgery. For example, acannula (e.g. a single lumen cannula) may be inserted entirely into theorifice and/or a distal end of the cannula may be inserted through anincision in a wall of the orifice into the body cavity.

Optionally, where the apparatus includes a cannula extension, a proximalextension to the cannula may be inserted into the orifice where a distalend of the extension is connected to the proximal end of the cannula.Additionally or alternatively, in some embodiments, a proximal end ofthe extension is accessible from outside the orifice. Optionally theorifice may be sealed around the proximal extension and/or the channelmay be sealed.

In some embodiments, an incision may be supplied in a wall of anorifice, providing access to a body cavity. Optionally, the incision maybe made by a surgical procedure. Optionally, the incision may be dilatedto a desired shape and size. For example, the incision may be dilated tohave dimensions similar to the distal cross section of the cannula.

In some embodiments, a cannula may have cross section similar to a crosssection of a portion of the orifice (for example, at one or moredimensions of the maximum outer cross section of the cannula may rangebetween 90 to 100 percent and/or 70 to 90 percent and/or 40 to 70percent of corresponding dimensions of the smallest cross section of theorifice between the outer opening of the orifice and the incision). Forexample, the ratio of the a large dimension to a small dimension ofcannula may range between 90 to 110 percent and/or between 70 to 130percent and/or between 50 to 150 percent the ratio of the long dimensionto the short dimension of a smallest cross section of the orificebetween the outer opening to the incision in the wall to the bodycavity. Optionally, a dilator may have a cross section and/or a ratio oflong cross section dimension to short cross sectional dimension similarto the cannula. For example, ratio of long and short dimensions of thedilator and/or the cannula (and/or lumen/s of the dilator and/orcannula) cross section may range between 1.1 to 1.5 and/or between 1.5to 3 and/or between 3 to 5. In some embodiments, a cross sectionaldimension (e.g. width) of a lumen of the cannula (and/or sheath) is, inat least one dimension, a width of at least 21 mm or about 21 mm or awidth of 5-50 mm, or 10-30 mm, or 15-25 mm, or lower or higher orintermediate dimensions or ranges.

In some embodiments, a cannula may be inserted through the orificeand/or into the cavity. Optionally, the cannula may be inserted entirelyinto the orifice. For example, a distal opening of the cannula may beinserted through the incision in the wall of the orifice into thecavity. For example, a proximal opening of the cannula may be positionedinside the orifice.

In some embodiments, the cannula may be stabilized inside the orifice.For example, the cannula may include a handle. The handle is optionallypositioned protruding out of the orifice. For example stabilizing thecannula may include holding the handle and/or by mounting the handle toa support outside the orifice.

Additionally or alternatively, in some embodiments, the cannula isstabilized by connection to a connector where, in some embodiments, theconnector includes a handle located outside the orifice. For examplestabilizing the cannula may include holding the connector handle and/orby mounting the handle to a support outside the orifice. In someembodiments, the connector is coupled to a seal (e.g. including aGelPOINT® cap) sealing the orifice.

In some embodiments, a cutting device may be used to open an incision ina wall of the orifice and/or the cannula may be guided along the cuttingdevice through the incision. Alternatively or additionally, a distalopening of cannula may be placed next to an incision location in thewall of the orifice and/or a cutting device may be inserted through thecannula to the incision site. For example the cutting device may includea needle and/or a laser and/or a blade and/or a dilator. Optionally thecutting device may be used to open an incision in the wall and then adistal portion of the cannula may be inserted through the incision.

In some embodiments, the cannula may be retained in the incision usingthe handle (e.g. cannula handle and/or connector handle). For example,there may be no other objects between the cannula and the sides of theincision. For example, there may no retainer inside the cavity (forexample a retainer may include a ring and/or a widened lip of thecannula and/or a retractor). Alternatively or additionally, a retainermay be inserted into the incision. For example, the incision may not besealed around the cannula. Alternatively or additionally, the incisionmay be sealed around the cannula.

In some embodiments, a proximal extension may be joined to a cannula.Optionally, a distal opening the extension may be joined to proximalopening of the cannula and/or a proximal opening of the extension may bein communication with an external opening of the orifice. For example, aproximal portion of the cannula may be inserted into a distal opening ofthe extension and/or a distal portion of the extension may be insertedinto a proximal opening of the cannula. Alternatively or additionally alinking tube and/or a locking link and/or a flexible link may be used tojoin a proximal opening of the cannula to a distal opening of theextension.

In some embodiments, the length of a channel may be adjusted. Forexample, the extension may be inserted into the orifice until a proximalopening of the extension reaches a desired location. For example theproximal opening of the extension may be positioned approximately flushwith an outer opening of the orifice. Alternatively or additionally, theproximal opening of the extension may be positioned protruding out ofthe orifice by a distance ranging between 1 to 5 cm and/or between 5 to10 cm and/or between 10 to 50 cm. Alternatively or additionally, theproximal opening of the extension may be positioned inside the openingof the orifice by a distance ranging between 1 to 2 cm and/or between 2to 5 cm and/or between 5 to 10 cm. Optionally the length may be adjustedwhile the lumen of the cannula remains in communication with the lumenof the extension. For example, the length of the channel may be adjustedbe telescopic sliding of the extension with respect to the cannula.

In some embodiments, the orifice may be sealed around the channel.Optionally, the extension (or cannula in the case of apparatus with afixed length cannula, or in the case of a telescoping cannula where theextension is part of the cannula) may be configured for sealing anopening of the orifice. For example, a sealing apparatus may be attachedto the extension (or cannula). For example, in some embodiments, thesealing apparatus may include a sleeve and/or an access cap. Optionallythe seal will preserve positive pressure in the orifice and/or the bodycavity. For example, the pressure in the cavity may be greater than theexternal atmospheric pressure. Pressure in the orifice may be maintainedat a positive pressure differential with respect to the externalatmosphere by between 90 to 100 percent and/or between 70 to 90 percentand/or 40 to 70 percent and/or 10 to 40 percent as large as the pressuredifferential between the body cavity and the external atmosphere.

In some embodiments the seal on the orifice may allow access to thechannel (and/or by means of the channel to the body cavity) and/or tothe orifice. For example, a seal may include one or more ports to thechannel and/or a seal may include one or more ports to the orifice (e.g.the space between an outer wall of the channel and an inner wall of theorifice). Optionally some or all of the ports may be sealable e.g. by asealing element e.g. by a cap fitted to a proximal end of the port/s.

For example, using a port, an instrument may be inserted into theorifice and/or into the channel and/or through the channel into thecavity. In some embodiments, the sealing element (e.g. cap) forms a sealbetween the instrument and the port.

Alternatively or additionally, a gas and/or liquid may be introduced viaa port into the orifice and/or into the channel and/or through thechannel into the cavity.

In some embodiments, a handle of the cannula may pass through a portinto the orifice. For example a proximal end of the handle may be passedthrough the seal and/or the seal may be positioned onto an opening ofthe orifice. Optionally, the seal (and/or a sealing element coupled to aport through which the handle passes) may provide a pressure seal aroundthe handle and/or allow manipulation of the cannula.

An aspect of some embodiments of the current invention relates tosupplying a pressure seal for a natural orifice and a channel throughthe orifice, where the channel provides access to a body cavity. In someembodiments, the channel includes a lumen of a cannula, e.g. a singlelumen cannula. Optionally, the pressure seal will preserve a pressuredifferential between the orifice and/or channel and an outer atmosphere.In some embodiments there may be pressure communication between thecavity and the orifice and/or the cavity and the channel. Optionally theseal may preserve pressure in the orifice and/or the channel and/or thebody cavity.

In some embodiments, there may be pressure and/or fluid (e.g. liquidand/or gas) communication between the channel and the orifice and/orbetween the orifice and the cavity and/or between the cavity and thechannel. For example, an incision may allow communication between thebody cavity and the orifice and/or between the body cavity and thechannel. For example, the channel may include openings to the orificeand/or space between parts of the channel may allow communicationbetween the channel and the orifice.

In some embodiments, there may be no active preservation of pressuredifferential between the channel and the body cavity. For example, theremay be no active preservation of pressure differential between thechannel and the orifice. For example, there may be no activepreservation of pressure differential between the orifice and the bodycavity. For example, there may not be a seal on the incision. Forexample, there may not be a seal between the cannula and the incision.For example, the walls of the channel may not be sealed against theorifice. Optionally, the pressure seal may preserve approximately equalpressure in the channel, the orifice outside the channel and/or the bodycavity. For example, the pressure differential between the cavity andthe outer atmosphere may be between 90 to 110 percent and/or between 80to 120 percent and/or between 60 to 140 percent and/or between 30 to 200percent the pressure differential between the orifice and the outeratmosphere. For example, the pressure differential between the cavityand the outer atmosphere may be between 90 to 110 percent and/or between80 to 120 percent and/or between 60 to 140 percent and/or between 30 to200 percent the pressure differential between the channel and the outeratmosphere. For example, the pressure differential between the channeland the outer atmosphere may be between 90 to 110 percent and/or between80 to 120 percent and/or between 60 to 140 percent and/or between 30 to200 percent the pressure differential between the orifice and the outeratmosphere. Optionally the pressure differential between the cavity andthe outer atmosphere may range between 2 to 4 mm Hg and/or between 4 to8 mm Hg and/or between 8 to 12 mm Hg and/or between 12 to 16 mm Hgand/or between 16 to 30 mm Hg. For example the pressure differentialbetween the cavity and the outer atmosphere may be maintained viainsufflation. For example, insufflation may be achieved by applyingpressurized gas, for example air and/or Carbon Dioxide and/or Nitrogen.

Optionally in some embodiments a seal for an orifice (the seal, in someembodiments including a GelPOINT® cap) may include a port providingaccess from outside the orifice to the body cavity. For example aportion of a channel (e.g. extending from a distal face of the seal tothe cavity) may pass through the seal. For example, a proximal openingof the channel may be exposed to an external atmosphere outside the seal(e.g. at a proximal face of the seal). Optionally there may be a cap forclosing and/or limiting communication between the channel and the outeratmosphere.

In some embodiments, access to the body cavity is supplied through thechannel passing through the orifice. Optionally the channel includes aproximal opening outside of a sealed portion of the orifice. Optionallya cap is supplied to the proximal opening of the channel. For example,the cap may preserve pressure in the orifice and/or in the channeland/or in the body cavity. In some embodiments, the cap may include oneor more openings (also herein termed “ports”) e.g. providing access tothe channel. The ports are optionally sized and shaped to allow entranceand/or seal around a tool, for example a catheter and/or endoscopeand/or surgical mechanical arm (e.g. cylindrical surgical mechanical armfor example, including one or more feature of surgical arms describedand/or illustrated in U.S. Pat. No. 10,022,197 and/or which is hereinincorporated by reference in its entirety). In an exemplary embodiment,the cap includes one or more opening sized and/or shaped to allowentrance and/or seal around a cylindrical element of 1-20 mm, or 5-10mm, or about 8 mm diameter, or lower or higher or intermediate ranges ordiameters. Optionally multiple ports in the cap allow insertion ofmultiple tools into the channel for example as illustrated in FIGS. 2and/or 6B and/or 8B and/or 13H-J.

Optionally, the channel may include one or more guides to guide a toolalong the channel. In some embodiments, a port across the seal to thechannel will be used for fluid communication.

In some embodiments, the cannula cross section has a long dimension anda short dimension where maximum widths (e.g. elastically relaxed widths)of the openings are smaller than the short dimension and a sum of themaximum widths (e.g. elastically relaxed widths) of the openings issmaller than the long dimension. Potentially, this means that surgicalinstruments which are inserted through the openings are suitably sizedfor insertion into the cannula. In some embodiments, this sizing of theopenings and cannula potentially controls orientation of insertion ofcoupled surgical instruments. For example, in some embodiments, surgicalarms coupled proximally (e.g. at motor units) in a linear configuration(e.g. in a row) are inserted through the openings where the orientationof the linear configuration through the cannula is controlled by thesizing of the openings.

In some embodiments, the seal includes one or more ports allowing accessto the orifice. For example, a handle may pass through the seal betweenthe orifice and the external atmosphere. For example, the handle may beused for stabilizing a portion of the channel and/or a distal opening ofthe channel and/or the incision. In some embodiments the port in theseal may supply access to the orifice outside the channel (for examplefor an instrument and/or for fluid communication).

In some embodiments, a port extends through most of the channel. Forexample, in some embodiments, a sheath including at least one lumen(e.g. a single lumen) extends through the sealing element through aportion of a length of the channel. Where the portion of the channellength is 50-99%, or 70-99%, or lower or higher or intermediatepercentages or ranges. For example, in some embodiments, a long axislength of the sheath (and/or a portion of the sheath configured toextend distally from a distal face of the sealing element) is 50-99%, or70-99%, or lower or higher or intermediate percentages or ranges of along axis of the cannula (and/or a portion of the cannula configured toextend distally from the distal face of the sealing element).

In some embodiments, an access opening to the orifice e.g. through theseal is self-sealing, for example, closed when an instrument is notinserted through the opening. A potential benefit being that a pressuredifferential may be maintained by the seal when instrument/s are notinserted into the sea. For example, one or more port is self-sealingand/or sealable e.g. includes portions which elastically deform to allowinsertion of an instrument e.g. include a duckbill seal e.g. a cannulaseal e.g. one or more opening of a cap.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings and/or the Examples. The invention iscapable of other embodiments or of being practiced or carried out invarious ways.

Variable Length Channel and Access Seal

FIG. 1 is a schematic illustration of a variable length channel insertedthrough a natural orifice in accordance with embodiments of the currentinvention.

In some embodiments, the channel may include multiple sections.Optionally, a distal section is open to a body cavity, for examplethrough an incision in the wall of the orifice. Optionally an externalopening of the orifice is sealed around a proximal portion of thechannel. In some embodiments, the distal section of the channel isstabilized from outside the orifice.

In some embodiments, a channel 114 with proximal opening to outside asubject, passes through a natural orifice 100 and/or includes a distalopening 109 to a body cavity 102 of the subject. Optionally, a distalcannula 108 includes a distal opening 109 inserted through an incision107 in the wall of orifice 100 to the body cavity 102. For exampleincision 107 may be made in tissue (e.g. a natural membrane) 106 (forexample a rectovaginal septum separating the vagina from the rectouterine pouch. Optionally a proximal opening 105 of cannula 108 ispositioned inside the orifice 100. Optionally, proximal opening 105 isin communication with a distal opening 115 of a proximal extension 110of the channel 114. For example, the distal opening 115 of the extension110 and the proximal opening 105 of the cannula may overlap. Forexample, the cannula 108 may slide telescopically inside the extension110. Alternatively or additionally, the extension 110 may slidetelescopically inside the cannula 108. Optionally, cannula 108 and/orextension 110 are rigid. Alternatively or additionally one or both of acannula and/or an extension may be flexible with a fixed cross section.Alternatively or additionally one or both of a cannula and/or anextension may have a variable cross section. In some embodiments, adistal portion of cannula may be flexible while handle remain rigidlyconnected to the distal opening of the cannula.

In some embodiments, cannula 108 is stabilized from outside the orifice.For example, cannula 108 may include a handle 116 that projectsproximally beyond proximal opening 105. For example, handle 116 mayproject out beyond a seal 112 on the opening of the orifice 100.Optionally, handle 116 may be rigidly connected to cannula 108.Optionally, an external and/or proximal and/or protruding portion ofhandle 116 may be held by an operator and/or connected to an instrumentholder (for example as illustrated in FIG. 9). For example, using handle116 the distal opening 109 of cannula 108 may be held inside of cavity102. Optionally, the cannula may not include a retaining mechanism (suchas a retaining ring, a suture, a balloon and the like) to keep thedistal opening of the cannula 108 inside cavity 102.

In some embodiments there may be fluid and/or pressure communicationbetween the cavity and the orifice. For example, the cannula may beinserted directly through incision 107 and/or may not include a sealingmechanism separating cavity 102 from orifice 100. For example, thesystem may allow leakage of fluid and/or pressure between cavity 102 andorifice 100. Alternatively or additionally, the connection betweencannula 108 and extension 110 may allow leakage of fluid and/or pressurebetween channel 114 and orifice 100.

In some embodiments, proximal section 110 of a channel 114 may include aseal 112. For example, seal 112 may be sized and shaped to seal orifice100 around channel 114. For example, seal 112 may include a cap and/or asleeve, for example as illustrated in FIGS. 6A, 6B and/or 9. Optionally,the seal may include one or more channels allowing access to theorifice, for example as illustrated in FIGS. 2 and/or 6B. For example,seal 112 may limit pressure and/or fluid communication between orifice100 and an outer atmosphere. Optionally, a proximal opening 113 ofchannel 114 (which optionally includes a proximal opening of extension110) may be exposed outside seal 112 and/or may supply access to channel114 from outside the subject. Optionally, opening 113 may include a capfor example as illustrated in FIGS. 6B, 7 and/or 10. For example the capmay limits pressure communication and/or fluid between orifice channel114 and an outer atmosphere.

In some embodiments, extension 110 is stabilized. For example, extension110 may be stabilized by its connection to orifice 100, for example byseal 112. Alternatively or additionally, an extension may be connectedto an external body part of the subject (for example skin 104).Alternatively or additionally, extension 110 may include a handle and/orbe held by an operator and/or be connected to an instrument holder.

In some embodiments, orifice 100 may include a lumen e.g. a vagina.Optionally, cavity 102 may include a pouch of Douglas and/or anabdominal cavity (for example as illustrated in FIG. 11).

FIG. 2 is a schematic illustration of an access channel inserted througha natural orifice to a body cavity and/or sealed to a natural orifice inaccordance with embodiments of the current invention.

In some embodiments a seal 112 controls pressure and/or fluid exchangesbetween an external atmosphere and internal portions of a subject, forexample channel 114, orifice 100 and/or cavity 102. In some embodiments,there may be free pressure and/or fluid communication between channel114 and orifice 100. Alternatively, pressure and/or fluid communicationbetween channel 114 and orifice 100 may be limited. In some embodiments,there may be free pressure and/or fluid communication between cavity 102and orifice 100. Alternatively, pressure and/or fluid communicationbetween cavity 102 and orifice 100 may be limited. In some embodimentschannel 114 runs through a cannula 208. Optionally cannula 208 may havea variable length. For example, cannula 208 could include twotelescoping parts (for example cannula 108 and/or extension 110 of FIG.1). Alternatively or additionally, cannula 208 may include a single partwith variable length, for example a bellows. Alternatively oradditionally, cannula 208 may be flexible. Alternatively oradditionally, cannula 208 may be rigid.

In some embodiments, an operator may keep a positive pressure in cavity102. Optionally the pressure in cavity 102 will approximately equalizewith the pressure in channel 114 and/or orifice 100.

In some embodiments, seal 112 may include one or more ports. Optionally,there may be one or more ports from outside the subject to orifice 100,for example port 119. Optionally, there may be one or more ports fromoutside the subject to channel 114, for example ports 118 a and/or 118b. For example, ports 118 a and/or 118 b may allow insertion of multipletools simultaneously into channel 114 and/or through channel 114 intocavity 102. Each port may include a cap and/or a seal. For example, eachopening may be completely open and/or sealed around a tool and/or eachopening may be completely sealed. Optionally a marker may show a lengthof channel 114.

Method of Accessing a Body Cavity Through an Orifice

FIG. 3 is a flow chart illustration of a method of accessing a bodycavity through a natural orifice in accordance with embodiments of thecurrent invention. In some embodiments a variable length channel isinserted through a natural orifice to a body cavity. Optionally, theorifice is sealed around the channel.

In some embodiments, the cavity may be insufflated. Optionally,insufflation may be achieved via a route other than orifice 110.Alternatively or additionally, insufflation may be achieved via orifice110. Alternatively or additionally, cavity 102 may not be insufflated.

In some embodiments, an incision is made 307 between a natural orificeand a body cavity. For example, the incision may be made 307 in a wallof the orifice, for example in a membrane in the wall of the orifice.For example, the incision may be made 307 by first puncturing the walland then expanding the puncture with one or more dilators. Alternativelyor additionally, another method may be used to produce the incision.Alternatively or additionally, an opening between the orifice and thecavity be naturally occurring and/or have resulted from a pathologicalcondition and/or remain from a previous procedure.

In some embodiments, a cannula may be inserted 308 into the orifice. Forexample, the cannula may include a distal portion of a channel that willsupply access through the orifice to the cavity. Optionally, the cannulamay be inserted 308 after making 307 the incision. For example, thecannula may be inserted 308 into the orifice until a distal portion ofthe cannula passes through the incision and/or until a distal opening ofthe cannula is positioned inside the cavity. Optionally a guide may beused to guide the cannula to the incision. For example, the cannula mayfit around a dilator and/or the dilator may be used as a guide thecannula to the incision. Alternatively or additionally, the cannula maybe inserted into the orifice before making 307 the incision. Forexample, the cannula may be positioned with a distal opening at anincision location and/or a needle and/or a dilator may be insertedthrough the cannula to make the incision.

In some embodiments, after insertion 308 of the cannula into theorifice, the length of the channel is adjusted 310. For example, thecannula may be shorted than the orifice. For example, the proximal endof the cannula may be located inside the orifice. Optionally, anextension is joined to a proximal opening of the cannula. For example, alumen of the extension may be placed in communication with a lumen ofthe cannula. For existence, a distal opening of the extension may bejoined to a proximal opening of the cannula. Optionally, the cannula andextension may move relative to one another to adjust 310 the length ofthe channel. For example, the cannula and extension may be connectedtelescopically for example as illustrated in FIG. 1. Alternatively oradditionally, the channel may include an extendable element, for examplea bellows. In some embodiments, the cannula may be extended to form achannel of the desired length. For example, with the distal opening ofthe channel inserted 308 through the incision, a proximal opening mayreach an opening of the orifice (for example the length of the channelmay be adjusted to be approximately equal to the length of the orifice).Alternatively or additionally, the cannula may be longer than necessaryand/or the cannula may be contracted to the desired length. In someembodiments a length of the channel may be indicated, for example asillustrated in FIG. 7.

In embodiments, the orifice may be sealed 312. Optionally, a seal may beattached to the channel for example as illustrated in FIGS. 1, 2, 5, 7and/or 9. For example, the orifice may be sealed around the channeland/or the channel may be closed with a cap. Optionally one or moreports may be supplied to the orifice and/or to the channel, for exampleas illustrated in FIGS. 2, 4, 5 and/or 7. Optionally, the seal maycontrol leakage of pressure from the cavity within the orifice. Forexample, the pressure between the cavity and/or the orifice and/or thechannel may be equilibrated and/or a pressure difference between thecavity and/or the orifice and/or the channel and/or external atmospheremay be preserved.

In some embodiments, the cannula may be supported 316 from outside theorifice. For example, the cannula may include a handle that projects outfrom the orifice, for example as illustrated in FIGS. 1, 5, 6A and/or6B. For example the handle may be supported 316 on an instrument holder,for example as illustrated in FIG. 9. Alternatively or additionally, thehandle may be held by an operator. Optionally a seal may controlcommunication of fluid and/or pressure around the handle. In someembodiments, the distal opening of the cannula may be stabilized insidethe cavity by supporting 316 the cannula on an external support.Alternatively or additionally, there may be a retainer in the cavity forstabilizing the distal opening of the cannula inside the cavity. Forexample, one the cannula and/or the orifice seal is in place, theinstrument holder may be aligned to the handle of the cannula. Thehandle is optionally then locked in place to the instrument holder.

Method of Sealing a Channel and/or an Orifice

FIG. 4 is a flow chart illustration of a method of sealing a naturalorifice access channel to body cavity in accordance with embodiments ofthe current invention. In some embodiments, a channel may be suppliedthrough a sealed orifice to a body cavity. Optionally one or more portsmay supply access to the orifice and/or to the channel.

In some embodiments, an incision may be made 307 between the orifice andthe cavity and/or a cannula inserted 308 into the orifice and/or anopening of the orifice may be sealed 312, for example as illustrated inFIG. 3.

In some embodiments one or more ports may be supplied 418, 419 through aseal to an orifice and/or to the channel. Optionally each port may sealindependently to an instrument and/or may be separated sealable withoutan instrument. For example, a seal may include a gel closure. The portsmay be cut into the closure. For example, a preshaped introducer mayform ports in the closure, for example by puncturing the closure.Optionally an opening may be made with a non-circular shape. Forexample, the opening may be sized and shaped to fit the cross section ofextension 510 for example as illustrated in FIG. 5 of extension 710 forexample as illustrated in FIGS. 7 and/or 9.

In some embodiments, one or more ports may be supplied 418 to thechannel. For example, a cross section of the cannel may include a longdimension and a short dimension. Multiple ports may be arranged alonglong dimension of the channel. For example, each tool may take up atsubstantially all off the short dimension of the channel cross section.For example, two instruments may fit side by side along the long ledimension of the cross section, but may not fit side by side along theshort dimension.

In some embodiments, one or more access ports may be supplied 419 to theorifice. For example, a port through the seal to the orifice may includea port sized and shaped to fit a handle of a uterine manipulator. Forexample, a port through the seal to the orifice may include a port sizedand shaped to fit the handle of the cannula, for example as illustratedif FIGS. 5, 6B, 7 and/or 10.

FIG. 5 is a photograph of components of an access channel to body cavityin accordance with embodiments of the current invention. In someembodiments, a cannula is shaped to fit into a natural orifice.Optionally, a dilator is shaped to fit through the cannula and/or toopen an incision shaped and sized to fit a distal portion of thecannula. Optionally, a distal portion of an extension of the channel ismade to fit a proximal portion of the cannula. Optionally, the extensionincludes a seal configured to limit pressure and/fluid communicationbetween the orifice and an external atmosphere.

In some embodiments, a cannula 508 is shaped to fit through a naturalorifice. For example, cannula 508 has a wide flat cross section thatfits a vagina. For example, cannula 508 has a cross section with a longdimension that is approximately twice its short dimension. Alternativelyor additionally, the ratio of the long dimension to the short dimensionmay range between 1.1 to 1.6 and/or between 1.6 to 2.4 and/or between2.4 to 3.0 and/or between 3.0 to 5.0. For example, for vaginal entry thelong dimension of the cross section may range between 2 to 5 cm.

In some embodiments, cannula 508 includes a handle 516. Optionally,handle 516 extends proximally beyond a proximal opening 505 of thecannula. For example, handle 516 may extend proximally to proximalopening 505 a distance ranging between 0.5 to 1 and/or 1 to 2 timesand/or 2 to 5 times the distance from proximal opening 505 to a distalopening 509 of the cannula. For example, handle 516 may be used tosupport cannula 508, for example as illustrated in FIGS. 3 and/or 9.

In some embodiments, a set of a first dilator 526 a and/or a seconddilator 526 b are shaped to pass through cannula 508. For example,second dilator 526 b may have dimensions that fit snugly through cannula508. For example, the outer cross section of dilator 526 b may rangebetween 0.99 to 0.8 times and/or between 0.8 to 0.6 times the innercross section of cannula 508. Optionally, first dilator 526 a fitssnugly into second dilator 526 b. Optionally, a needle 527 and/or aneedle holder 531 are supplied. For example, needle 527 fits throughdilator 526 a. For example, needle 527 may be used to puncture aninitial incision in a wall of the orifice. Dilators 526 a and/or 526 bmay be used successively to open the initial incision large enough tofit the distal portion of cannula 508 through the incision into a bodycavity of a subject.

In some embodiments an extender 510 may be joined to cannula 508. Forexample, a distal opening 515 of extender 510 may be joined to proximalopening 505 of cannula 508 for example as illustrated in FIG. 1 and/orFIG. 3.

In some embodiments, extender 510 may be connected to a seal 512. Forexample, seal 512 may be shaped and sized to seal the orifice, forexample as illustrated in FIGS. 1, 2, 3 and/or 4. Optionally, seal 512may include ports opening to extender 510 and/or the orifice, forexample as illustrated in FIGS. 1, 2, 3, 4 and/or 7. For example,multiple tools may fit side by side along the long dimension of thecross section of extension 510 and/or cannula 508.

FIG. 6A is a schematic illustration of inserting a cannula into anatural orifice in accordance with embodiments of the current invention.In some embodiments, a sleeve may be inserted into an opening of anorifice. Tools are optionally inserted through the opening to make anincision in a wall of the orifice. For example, the cannula may beinserted as illustrated in FIGS. 1, 3 and/or 9.

In some embodiments a sleeve 620 may be inserted into an orifice 100.For example, sleeve 620 may include a retractor and/or an anal portand/or a speculum. Optionally a cannula 608 may be inserted entirely(e.g. both a proximal opening and distal opening of cannula 608 may beinserted) into orifice 100. Optionally, a handle 616 may protrude out ofthe orifice 100 and/or be used to support the cannula 608. Optionally, adistal opening of the cannula 608 may be inserted into a body cavity 102through an incision in a wall of the orifice. Optionally another tool622, for example a tenaculum and/or a uterine manipulator may beinserted into orifice 100.

FIG. 6B is a schematic illustration of sealing a channel to a naturalorifice in accordance with embodiments of the current invention. In someembodiments, a seal 612 may be fit to sleeve 620. Optionally seal 612may limit pressure and/or fluid communication between orifice 100 and anouter atmosphere (for example as illustrated in FIGS. 1, 2 and/or 3).Optionally, seal 612 may include ports opening access to orifice 100and/or cannula 608. For example a cap 666 may include two ports 618 aand/or 618 b including proximal openings 614 to a channel leading tocannula 608 and/or an incision and/or a body cavity 102. Using ports 618a and/or 618 b two tools can independently be inserted through a singlechannel (e.g. cannula 608) and/or a single incision through orifice 100and/or into cavity 102. Alternatively or additionally, cap 666 containsanother port to orifice 100. For example handle 616 may protrude throughthe additional port. Optionally, a second cap 624 covers another port619. For example, port 619 may serve for inserting tool 622 into orifice100.

FIG. 7 is a photograph of a variable length channel and orifice seal inaccordance with embodiments of the current invention. In someembodiments, a cannula is joined to extender to form a channel throughan orifice. Optionally, the extender is connected to a seal for anopening of the orifice. A handle connected to the cannula optionallypasses through the seal to support the cannula from outside the orificefor example as illustrated in FIGS. 1, 2, 3 and/or 4. Optionally, thehandle is graduated. For example, the system of FIGS. 1, 2, 3, 4 and/or7 may be used for transorifice laparoscopy.

In some embodiments, a cannula 708 is joined to an extender 710. Forexample together, the cannula and extender may form an access channelfor transvaginal Culdoscopy. Optionally the extender 710 includes a seal712. For example seal 712 limits pressure and/or fluid communicationbetween the orifice and an outer atmosphere. For example seal 712 may beattached to extension 710, for example on a proximal portion thereof.

In some embodiments, extender 710 slides over cannula 708. Sliding ofextender 710 over cannula 708 optionally telescopes (for example toextend or contract) a transvaginal access channel.

In some embodiments a handle 716 is connected to cannula 708. Forexample handle 716 extends proximally from cannula 708. Optionally,during use, handle 716 protrudes out seal 712 and/or is used to supportcannula 708. In some embodiments, as cannula 708 slides with respect toextension 710, handle 716 slides with respect to seal 712.

In some embodiments, an indicator informs an operator of the length ofthe channel. For example, graduations are marked on handle 716. Thegraduations, for example, indicate the length of the access channel. Forexample, knowing the length of the access channel may assist an operatorknow how far to insert tools and/or dilators and/or may assist determinethe proper placement of the cannula 708.

Optionally seal 712 includes one or more ports. Optionally, one or moreports are open to the orifice and/or the channel. For example, a port719 may be open through seal 712 to the orifice. For example forculdoscopy, the orifice includes a vagina. For example port 719 may beused to control a uterine manipulator. Optionally a cap 724 limitspressure and/or fluid communication through port 719. Optionallymultiple ports 714 may open to extension 710 and/or a channel throughthe orifice and/or a body cavity. Ports 714 are optionally used forindependent access of multiple tools to a body cavity, for example arecto uterine pouch. In some embodiments, a cap 766 limits pressureand/or fluid communication between an outer atmosphere and/or theorifice and/or the channel. Optionally, seal 712 includes a further portto the orifice. For example, handle 716 passes through the port betweenthe orifice and an external space. Optionally, cap 766 includes a slitthrough which handle 716 passes. For example the slit may limit pressureand/or fluid communication through the port and/or around handle 716.

FIG. 8A is a schematic illustration of preparing an orifice seal inaccordance with embodiments of the current invention. For example, anintroducer including dilators 826 may be used to poke one or more holesin a seal 812 and/or dilate and/or open existing hole/s. For example,the holes may include ports 618 a and 618 b and/or a third port into aseal 812. In some embodiments, a plurality of holes in seal 812 and/ortwo or more ports (e.g. two or more of ports 618 a, 618 b and the thirdport) are provided by a single port element. In some embodiments, a portelement includes a single channel extending from a proximal face of theseal to a distal face of the seal (the channel is also termed “port”).In some embodiments, a port element includes a plurality of suchchannels or “ports”.

For example ports 618 a and 618 b may provide access to a cross orificechannel. The third port may supply access to the orifice, for examplefor a handle of a cannula. In some embodiments, an introducer mayinclude multiple dilators 826 and/or a handle 828. Optionally, theintroducer may make multiple holes in a predefined pattern. For example,as illustrated in the figure, the introducer makes a set of three holesin a seal in a geometry suited for ports 714 to the trans orificechannel and/or the orifice and/or to form ports in a geometry that fitcap 766 and/or extender 710 and/or handle 716.

FIG. 8B is a simplified schematic of an orifice seal 812 and a portelement 891, according to some embodiments of the invention. In someembodiments, port element 899 provides a plurality of channels throughseal 812. For example, in some embodiments, port element includes ports618 a, 618 b, 618 c (port 618 c also termed “the third port). In someembodiments, port element 891 is a single piece. In some embodiments,port element 891 includes a base 893 which is configured (e.g. sizedand/or shaped) to prevent ports from passing through seal 812. In someembodiments, base 893 connects one or more of ports 618 a, 618 b, 618 c.In some embodiments, base 893 has at least one dimension perpendicularto an axis of a lumen of one or more of the ports which is larger thanall cross sectional dimensions of one or more of the ports e.g.potentially preventing the port/s and/or port element from passingthrough seal 812. In some embodiments, the port element provides supportand/or guidance to instrument/s inserted through the port element. Insome embodiments, a handle connected to a cannula (e.g. handle 116FIG. 1) extends through the third port, the port element therebyproviding support to instrument/s inserted through one or more of ports618 a, 618 b which is stabilized by the handle.

FIG. 9 is a photograph of a variable length channel and orifice sealconnected to a support in accordance with embodiments of the currentinvention. Optionally, during use of an access system including avariable length channel, a distal portion of the channel may be held bya support.

In some embodiments, the channel and/or the orifice seal may be held bya support. Optionally, support 932 may be outside the subject. Forexample, handle 716 of cannula 708 is held by a support 932. Optionally,the subject is immobilized. For example, support 932 maintains a distalopening of cannula 708 inside a body cavity of the subject. For example,while held in the subject, the channel may be used for access to thecavity, for example for surgery.

In some embodiments, a sleeve 930 may be positioned in an entrance to anorifice, for example a vagina. Optionally sleeve 930 is attached to seal712. For example, sleeve 930 may include a retractor, (for example anAlexis® wound retractor*). Seal 712 optionally includes an access cap(for example a GelPOINT® cap*) [* both available from Applied Medical22872 Avenida Empresa, Rancho Santa Margarita, Calif. 92688]. In someembodiments, a distal end of sleeve 930 includes a base portion. In someembodiments the base portion is configured to anchor the sleeve insidethe orifice. For example, in some embodiments, the base portion is sizedand/or shaped to remain in position within the orifice e.g. elasticityof the orifice tissue holding the base portion in place. Alternativelyor additionally, in some embodiments, the base portion includes aportion which is elastic, the portion being elastically compressed,positioned within the orifice and released, elastic forces of the baseportion against the orifice tissue holding the base portion in place. Insome embodiments, the base portion includes a reinforced ring which is,in some embodiments, elastic e.g. including silicone rubber. A potentialadvantage of the base portion is that it, in some embodiments, holds thesleeve in position and/or holds the sleeve open potentially preventinginterference of the sleeve with other elements and/or provides sealingat the natural orifice.

In some embodiments, the channel is longer than sleeve 930. For example,a distal portion of cannula 708 may project longitudinally, past (and/orthrough) sleeve 930. For example, a distal portion of cannula 708 mayproject into a body cavity, for example through an incision in a wall ofthe orifice, for example into a recto urinary pouch.

FIG. 10 is a photograph of an orifice seal end cap in accordance withembodiments of the current invention. For example two caps 724 and 766are illustrated in a package 938 Optionally, cap 766 includes a slit914. For example, slit 914 is sized and shaped fit to handle 716. Forexample, handle 716 may slide through slit 914. Additionally oralternatively, slit 914 may fit snugly to handle 716 and/or limitcommunication of pressure and/or fluid between the orifice and the outeratmosphere. Optionally the material of cap 766 (and/or cap 1325 FIGS.13H-J) provides a pressure seal but has low friction to allow thesliding movement. In some embodiments, cap 766 (and/or cap 1325 FIGS.13H-J) may be made of silicon or silicon with a friction reducing agentfor example a coating of parylene.

FIG. 11 is a schematic illustration of a distal portion of a channelinserted through a vagina into a pouch of Douglas in accordance withembodiments of the current invention. In the exemplary embodiment, thechannel passes through a natural orifice (e.g. a vagina 17) to provideaccess to a body cavity (e.g. a rectouterine pouch 19).

Reference is now made to FIG. 11, which schematically represents thepositioning of cannula 1108 relative to anatomical structures of afemale lower abdomen/pelvic region, according to some embodiments of thepresent disclosure. Among the anatomical structures shown are the uterus15, vagina 17, bladder 15, rectum 11, and rectouterine pouch 19. Notshown are the handle (for example handle 116) of cannula 1108, andoptional associated devices such as insufflation sealing which may beprovided for, e.g., at the vaginal orifice, and/or a proximal extension(for example extension 110) which may be telescopically fitted to extendthe length of cannula 1108.

In some embodiments, distal aperture 1109 of cannula 1108 is slanted atan angle between a leading distal-most edge portion 1111 a, and afollowing, more proximal edge portion 1111 b. The longitudinal distancebetween distal-most edge portion 1111 a and proximal-most edge portion1111 b, in some embodiments, is about 15 mm. In some embodiments, thedistance is about 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, or another longer,shorter, or intermediate distance. A potential advantage of the slantingof distal aperture 1109 is to allow the cannula edge to be relativelyretracted on an unprotected side of the cannula which could otherwise beaccidentally positioned to scrape the rectum 11. As for themore-protruding leading-edge side of the aperture 1111 b: (1) uponinsufflation, tissue is generally lifted away from the rectum, reducingcontact risk posed by this side, and (2) the robotic arms, where theyexit the cannula, will generally be curved across the plane of theleading edge as they reach deeper into the peritoneal space. Thispotentially prevents contact of the leading edge with delicate internaltissues.

Additional Exemplary Embodiments

FIG. 12 is a flow chart illustration of a method of providing sealedaccess to body cavity through a sealed natural orifice and/or sealedchannel, according to some embodiments of the invention.

At 1200, in some embodiments, a sealing unit connector (e.g. connector1318 FIGS. 13A-J) is coupled to a sealing element, also termed in thisdocument “seal”, (e.g. seal 1312 FIGS. 13A-J) which is sized and/orshaped to seal a natural orifice. In some embodiments, the sealingelement includes a GelPOINT® cap. In some embodiments, coupling is byinserting at least a portion of the sealing unit connector into and/orthrough the seal, for example, by creating and/or opening and/orenlarging an opening in the seal and inserting at least a portion of theconnector into and/or through the opening. In some embodiments, the sealincludes flexible and/or elastic material which is configured to sealaround the inserted connector.

Optionally, in some embodiments, insertion of the connector is using anintroducer (e.g. introducer 1301 FIGS. 13A-J). Where, in someembodiments, force applied to the introducer is transferred to the sealto create and/or open and/or enlarge the opening in the seal and/or toinsert one or more portion of the connector into and/or through theseal.

At 1202, optionally, in some embodiments the introducer is removed fromthe connector.

At 1204, in some embodiments a cannula (e.g. cannula 1310 FIGS. 13D, E,I and J) is inserted into the orifice and into the body cavity. In someembodiments, insertion is through the sealing element e.g. through alumen in the connector coupled to the sealing element.

At 1206, in some embodiments, a cannula seal (e.g. cannula seal 1311FIGS. 13E-G) is coupled to the cannula e.g. to a proximal end of thecannula which proximal end, in some embodiments, extends from a proximalface of the sealing element. In some embodiments, the cannula seal iscoupled to a proximal end of the connector, sealing the connector lumen,connection between the connector lumen and the cannula beingsufficiently close and/or including addition seal/s (e.g. an O-ringbetween the cannula and connector) so that the seal established betweenthe connector and the cannula seal also seals the cannula.

At 1208, in some embodiments, an sheath (e.g. sheath 1323 FIGS. 13H-I)is inserted into the cannula through the cannula seal. In someembodiments, the sheath

At 1210, in some embodiments, sheath seal, also termed “sheath cap”(e.g. sheath seal 1325 FIGS. 13H-J) is attached to a proximal opening ofthe sheath.

At 1212, in some embodiments, surgical instrument/s are inserted intothe cavity through opening/s in the sheath cap. In some embodiments, asingle surgical instrument is inserted into one or more sheath capopening.

In some embodiments, the sheath cap provides a seal around the surgicalinstrument/s potentially maintaining a pressure differential between thecannula and pressure external to the cannula. In some embodiments, thepresence of the cannula seal in addition to the sheath cap means thatwhen there are no instruments and/or less instruments than sheath capopenings inserted through the cap, a pressure differential between thecannula lumen and entrance to the openings is maintained. For example,allowing removal and/or insertion and/or exchange of instruments duringa procedure without losing pressure of the insufflated cavity.

FIGS. 13A-J are simplified schematics illustrating access and/or sealingapparatus, according to some embodiments of the invention.

FIG. 13A shows an introducer 1301 and a sealing unit connector 1318,according to some embodiments of the invention.

In some embodiments, introducer 1301 includes a distal portion 1328sized and/or shaped to fit into a lumen 1303 of sealing unit connector1318. In some embodiments, distal portion 1328 of introducer 1301includes a tapered dilator portion e.g. at a distal end of theintroducer.

In some embodiments, introducer 1301 includes a handle 1326 e.g. at aproximal end of introducer 1310. In some embodiments, handle 1326includes a portion which includes at least one cross sectional dimensionwhich is larger than an entrance to sealing unit connector lumen 1303.Potentially, this enables force applied to handle to be transferred toconnector 1318 e.g. so that a user applying force to the handle is ableto push connector 1318 into and/or through a seal.

In some embodiments, connector 1318 includes a lumen 1303. In someembodiments, connector 1318 includes a rim (which is, for example, aflange) 1307 at a distal end of the connector lumen. In someembodiments, connector 1318 includes a rim (which is, for example, aflange) 1305 at a proximal end of the connector lumen 1303. In someembodiments, one or both of rims 1305, 1307 have a larger crosssectional dimension that a central portion of the connector. Potentiallypreventing movement of the connector out of the seal and/or through theseal.

In some embodiments, connector 1318 includes a support 1309 which, insome embodiments, is coupled to additional element/s e.g. to preventmovement of the connector e.g. with respect to other apparatus and/or apatient.

FIG. 13B shows introducer 1301 coupled to sealing unit connector 1318and positioned in preparation for coupling to a seal 1312, according tosome embodiments of the invention. Where coupling is, e.g. by insertionof a distal portion of the introducer into the lumen of connector 1318.

In some embodiments, FIG. 13C shows sealing unit connector 1318 coupledto seal 1312, achieved, for example, by application of pressure tohandle 1301 until distal portion 1328 of the introducer pushes a distalportion of connector 1301 through into seal 1312 and/or a portion ofconnector 1310 through seal 1312. In some embodiments, introducer 1391pierces a hole through seal 1312. Alternatively, in some embodiments,introducer 1391 enlarges an existing hole within seal 1312.

In some embodiments, FIG. 13D shows a cannula 1310 positioned forentrance into connector lumen 1303 which lumen forms a channel throughseal 1312 (introducer 1301 has been removed from lumen 1303). In someembodiments, cannula 1310 has a single lumen 1315. In some embodiments,cannula 1310 has a rim (which is, for example, a flange) 1317 which, insome embodiments, is sized and/or shaped to be held by connector 1310e.g. potentially preventing the cannula from passing entirely throughlumen 1303 of connector 1318. In some embodiments, a cross section ofrim 1317 includes one or more dimension which is larger than a crosssectional dimension of lumen 1303.

In some embodiments, cannula 1310 includes one or more features asdescribed and/or illustrated regarding one or more of cannula 208 FIG.2, 508 FIG. 5, 608 FIGS. 6A-B, 708 FIGS. 7, 9.

In some embodiments, FIG. 13E shows sealing unit connector 1318 and seal1312 after cannula 1310 has been inserted through sealing unit lumen1303 and a cannula seal 1311 orientated ready for attachment to proximalopening/s of the sealing unit and/or cannula. In some embodiments, alumen cannula 1310, when connected to seal 1312 by connector lumen 1303forms a lumen passing through a natural orifice (e.g. as describedelsewhere in this document).

In some embodiments, FIG. 13F shows cannula seal 1311 and FIG. 13G showsa cross section of cannula seal 1311, according to some embodiments ofthe invention. In some embodiments, cannula seal 1311 includes aflexible portion 1313 sized and/or shaped to seal against a sheath (e.g.sheath 1315 FIGS. 13H-I). In an exemplary embodiment, flexible portion1313 is a duckbill gasket with a direction of protrusion of the duckbillinto lumen/s of the connector and/or cannula. In some embodiments,cannula seal 1311 includes a frame 1319. In some embodiments, frame 1319is rigid. In some embodiments, cannula seal connects to the connectorand/or cannula at the frame, which, in some embodiments, is sized and/orshaped to be held by a step 1321 between connector and cannula. Where,in some embodiments, step 1321 is present as a proximal end of thecannula is held recessed within connector lumen, a difference in sizebetween the cannula and the connector generating the step. For example,as illustrated in FIG. 13E.

In some embodiments, cannula seal 1311 and/or connector 1305 include aconnection geometry e.g. mating protrusion/s and/or indentations e.g. asnap-fit connection. In an exemplary embodiment, cannula seal 1311includes a protrusion 1351 sized and/or shaped to fit into a notch 1353in connector 1305. Potentially, such connection between the cannula seal1311 and connector increases robustness of the connection e.g.potentially preventing loss in sealing provided by the cannula sealunder use forces e.g. associated with insertion and/or removal ofinstruments e.g. associated with movement of the patient and/or ofpatient tissue.

In some embodiments, FIG. 13H shows a sheath 1323 and a sheath seal1325, also herein termed “sheath cap”. In some embodiments, sheath sealincludes a plurality of openings which, in some embodiments, areconfigured to each seal around a surgical tool. I For example, in someembodiments, one or more sheath seal opening is configured to sealagainst a surgical mechanical arm. In some embodiments, the sheath lumenand/or sheath seal and/or cannula seal and/or cannula lumen is sizedand/or shaped to receive (e.g. simultaneously) two cylindrical elements(e.g. surgical mechanical arms) of 1-20 mm or 5-10 mm, or about 8 mmdiameter or lower or higher or intermediate ranges or diameters. Where,in some embodiments, a space between the cylindrical elements is 0.5-20mm or 0.5-10 mm or 1-5 mm, or about 5 mm, or less than 5 mm or lower orhigher or intermediate distances or ranges. In some embodiments, a crosssection of said single lumen (and/or of a lumen of the sheath) has along dimension and a short dimension and each cap opening has a widthsmaller than the short dimension and the sum of the cap opening widthsis greater than the short dimension and less than the long dimension,e.g. potentially controlling an angle of insertion of coupled surgicalinstruments.

In some embodiments sheath seal is formed of flexible material e.g.silicone rubber. In some embodiments, sheath seal 1325 includes one ormore feature as described elsewhere in this document regarding cap/s,e.g. caps 624, 666 in FIG. 6B, caps 724, 766 in FIGS. 7, 9, and 10.

In some embodiments, FIG. 13I shows sheath seal 1325 coupled to sheath1323 (e.g. a proximal end of sheath 1323) and sheath 1323 being insertedinto cannula 1310. Where the sheath forms a channel through seal 1312and, in some embodiments, to cannula 1310. In some embodiments, cannulaseal 1311 is configured to make a seal between sheath 1323 and cannula1311 and/or the lumen of connector 1305.

In some embodiments, FIG. 13J shows the sheath fully inserted intocannula 1310. In some embodiments, an opening in the sheath (e.g. at thedistal end of the sheath) is disposed within cannula, for example,within a distal portion having 5%, or 10%, or 20% or 50% of a long axislength of the cannula. For example, in some embodiments, a long axislength of sheath is shorter than a long axis length of the cannula. Forexample, in some embodiments, a long axis length of the sheath is50-99%, or 80-99% or 80-99% of a long axis length of the cannula. Insome embodiments, the sheath and the cannula have substantially the samelong axis length e.g. within 1 mm, or 10 mm, or 20 mm of a distal endand/or opening of the cannula.

General

The terms “comprises”, “comprising”, “includes”, “including”, “has”,“having” and their conjugates mean “including but not limited to”.

The term “consisting of” means “including and limited to”.

The term “consisting essentially of” means that the composition, methodor structure may include additional ingredients, steps and/or parts, butonly if the additional ingredients, steps and/or parts do not materiallyalter the basic and novel characteristics of the claimed composition,method or structure.

As used herein, the singular forms “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise.

Whenever a numerical range is indicated herein (for example “10-15”, “10to 15”, or any pair of numbers linked by these another such rangeindication), it is meant to include any number (fractional or integral)within the indicated range limits, including the range limits, unlessthe context clearly dictates otherwise. The phrases“range/ranging/ranges between” a first indicate number and a secondindicate number and “range/ranging/ranges from” a first indicate number“to”, “up to”, “until” or “through” (or another such range-indicatingterm) a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numbers therebetween.

Unless otherwise indicated, numbers used herein and any number rangesbased thereon are approximations within the accuracy of reasonablemeasurement and rounding errors as understood by persons skilled in theart.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable sub combination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting.

What is claimed is:
 1. An access port for sealing an opening of anatural orifice and supplying access to a body cavity through thenatural orifice comprising: a sealing unit; an unobstructed single lumencannula extending to said body cavity; a connector connecting saidcannula to said sealing unit; said connector comprising a connectorlumen which defines an access opening through the sealing unit to saidsingle lumen; wherein said connector lumen comprises proximal and distalopenings, said proximal opening disposed proximal to a proximal face ofsaid sealing unit, said distal opening disposed distal of a distal faceof said sealing unit; and a cap including a plurality of cap openingsconfigured to seal between medical instruments inserted into said capopenings and said access opening.
 2. The access port of claim 1, whereinone or both of proximal and distal openings of said connector has aflange.
 3. The access port of claim 1, comprising an opening throughsaid sealing unit to the natural orifice.
 4. The access port of claim 1,wherein said natural orifice is a vagina.
 5. The access port of claim 1,wherein said cannula is open to an intraperitoneal cavity through saidnatural orifice.
 6. The access port of claim 1, comprising a sheathextending from a proximal face of said sealing unit, through saidsealing unit and through to said cannula lumen and extending within atleast a portion of a length of said cannula lumen.
 7. The access port ofclaim 6, comprising a cannula seal configured to seal one or both of aproximal opening of said cannula and a proximal opening of said sheath.8. The access port of claim 1, comprising a port element describing achannel through said sealing unit and opening to said cavity.
 9. Theaccess port of claim 1, comprising a port element describing a channelthrough said sealing unit and opening into said lumen of said cannula.10. The access port of claim 9, wherein said port element includes asheath extending from a proximal face of said sealing unit, through saidcannula and extending within a least a portion of said cannula.
 11. Theaccess port of claim 1, wherein a transverse cross section of saidsingle lumen has a long dimension and a short dimension; and whereineach of said cap openings has a width smaller than said short dimensionand the sum of widths of said plurality of cap openings is greater thansaid short dimension and less than said long dimension.
 12. The accessport of claim 11, wherein said cross section of said single lumen has,in at least one dimension, a width of at least 21 mm.
 13. The accessport of claim 1, wherein a transverse cross section of said single lumenhas a long dimension and a short dimension, and at least one of saidopenings has a width at least 90% the short dimension.
 14. A kit forproviding access to a cannula leading to a body cavity through a seal ona natural orifice comprising: a connector comprising: a channel with adistal opening and a proximal opening, said channel configured to passthrough said seal and attach to a cannula passing through the orifice tothe body cavity, said connector having a distal opening on an inner sideof said seal and a proximal opening on an outer side of said seal; a capcomprising a plurality of openings and sized and shaped to seal a lumenof said cannula; a sheath sized and shaped to pass through saidconnector and extend within at least a portion of said cannula lumen;and a sealing element sized and shaped to fit to one or both of saidsheath and said cannula and including elastically bendable flexibleportions which, when elastically relaxed, close a lumen of said sealingelement to seal one or both of said sheath and said cannula.
 15. The kitof claim 14, wherein said cap is sized and shaped to attach to one ormore of a proximal opening of said cannula, a proximal opening of saidsheath, and a proximal opening of said connector.
 16. The kit of claim14, wherein said distal opening of said connector has a cross sectionwith a long dimension and a short dimension and wherein said longdimension is at least twice said short dimension.
 17. The kit of claim14, further comprising an introducer for insertion of said connectorinto or through said seal, said introducer including a handle at aproximal portion of said introducer and a distal portion shaped andsized to fit into said channel of said connector; wherein said handlecomprises a portion which is larger than an entrance to said channel ofsaid connector.
 18. The kit of claim 17, wherein said distal portion ofsaid introducer comprises a tapered portion.
 19. The kit of claim 14,wherein said cap comprises a duckbill gasket defining a protrusion inthe direction of said cannula.